FDA – Fewer Approvals, Less to Talk About in 2016

As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had issued a total of only 6 press releases – 3 in each month. To put that in context, the monthly average for agency press releases during 2015 was 14.

The October/November period of relative quiet may just be an anomaly, but in fact overall during 2016 FDA has had less to say than it did the previous year. During  the first 11 months of 2015, FDA had issued a total of 146 press releases compared to the same period for this year when the agency issued only 112 – a 25 percent drop. In short, FDA has had less to say so far this year than it did last year.

A focus for FDA in 2015 involved approvals of new molecular entities – a record-setting 45 last year. To put that in perspective, between 2006 and 2014, new molecular entity approvals averaged 28 per year. During 2014, approvals were also high, coming in at 41.

But unless December gears up to be an exceptional month for such approvals, 2016 is not shaping up to be in the same league. At the mid-year point Eye on FDA check, it did not seem that FDA was on track to match last year’s robust approval rate. And in fact, so far in 2016 there have been only 19 approvals of new entities listed by the agency.  This is not only far short of last year, but unless at least 3 more approvals are announced this month, it will be a year with the fewest new entity approvals since 2010.

FDA of course approves more than new entities. There are also approvals of drugs that are not new molecular entities and many of those approvals (but not all) are announced in FDA press releases. Using press release announcements as a surrogate to measure that activity, approval actions still appear down. During the first 11 months of 2015, FDA announced via press release 69 approval actions involving drugs or biologics. By contrast this year during the same time period, there were only 27 such announcements. Of those, some included expanded approvals of already approved drugs, an OTC switch and a generic approval.

Could December be a comeback month?  It often is a period active with approvals. In 2015 there were 8 approval announcements for drugs or biologics in December. In 2014 there were a whopping 11 press releases about approvals, but in 2013, there were only 5. So while December could be a big month for year-end announcements, it is not a sure thing.

This week President Obama signed into law the 21st Century Cures Act and one of the chief aims of the legislation is to ease the way for the approval of new drugs, including drugs for rare diseases. While last year was a banner year for approvals, it would appear that 2016 may be a proof point for advocates of the law. In the meantime, we’ll wait and see if December brings a last minute rush of approvals (and releases) and in the new year, provide a detailed re-cap of press releases from FDA for 2016.

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